Traction apparatus and methods

ABSTRACT

A brace and traction device and associated methods of operation. In one embodiment, the device incorporates a forwardly open head and jaw brace which is adjustably supported vertically above a forwardly collar member. The brace and the collar member are adapted such that the brace is able to mate with the collar member while still being able to rotate to the subject&#39;s left and right while remaining planar to the collar member. Adjustment may be accomplished for example manually or via an electronic motor controlled by a control mechanism and microprocessor. The microprocessor may be adapted to store information regarding a user&#39;s sessions, and facilitate communication with patient and physician personal devices, thus sending these data from recorded sessions. The processor element may also be adapted to implement therapy sessions based on physician-entered program specifications, or based on pre-programmed specifications.

RELATED APPLICATIONS

This application is related to co-owned U.S. Pat. No. 7,128,724 issuedOct. 31, 2006 entitled “Cervical Spine Brace and Traction Device”, whichis incorporated herein by reference in its entirety.

COPYRIGHT

A portion of the disclosure of this patent document contains materialthat is subject to copyright protection. The copyright owner has noobjection to the facsimile reproduction by anyone of the patent documentor the patent disclosure, as it appears in the Patent and TrademarkOffice patent files or records, but otherwise reserves all copyrightrights whatsoever.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to apparatus and methods forutilizing and monitoring traction-based therapy, and specifically in oneexemplary aspect to a mobile cervical spine brace and traction devicewhich is able to provide electronic data regarding use to a patientand/or operator.

2. Description of Related Technology

By age 55, about 95% of the population will experience some degenerativecondition of the cervical spine that may cause neck pain and/or upperextremity pain and as much as one-third of that group may experienceweakness. These non-tumorous and non-infectious conditions may includedegenerative intervertebral discs, disc herniations, internal discdisruption, vertebral osteophytes or spur formation andspondylolisthesis, and they may potentially result in loss of discspace, height, encroachment on spinal nerve roots where they exit thespinal cord (radiculopathy), regional spinal cord compression(myelopathy) or vertebral joint instability. Moreover, yearlywork-injury-related neck and/or back pain may frequently affect as muchas 15 to 20% of the workforce; for example, the 1990 annual cost of neckand lower back care in the United States reached a staggering $85billion.

Management of cervical pain, radiculopathy and myelopathy is eithersurgical or conservative; these surgical or conservative approaches mayinclude anti-inflammatory medications, physical therapy, immobilizationand traction. Surgical patients are always at risk for surgicalcomplications including resultant quadriplegia and even death. Manyrecent publications by surgical and conservative therapists have, bothretrospectively and prospectively, compared short and long term outcomesbetween the two treatment groups, and the consensus appears to be that,in the majority of patients, the outcomes are not truly distinguishableat one year. Further, an intervention that would hasten the conservativerecovery process, such as by facilitating independent patientparticipation in his/her own care, would result in significanthealthcare cost savings.

Cervical traction is a technique where the weight of the head is removedfrom the cervical spinal axis and the cervical column is stretched inorder to relieve stress within the neck. This method can temporarilyremove much of the pain experienced by people with cervical disorders.Traction devices are well known in the medical field to facilitate theaccomplishment of the following: (i) regaining normal length andalignment of involved bone, (ii) reducing and immobilizing fracturedbone, (iii) lessening or eliminating muscle spasms, (iv) relievingpressure on nerves, especially spinal nerves, and (v) preventing orreducing skeletal deformities or muscle contractures. However, most ofthe currently available traction devices are very cumbersome anddifficult to use. Also, many must be used with direct interaction with aphysician or other healthcare provider and, therefore, deny the patientmobility when in traction. Because these problems often affect theeveryday lives of these patients, a portable traction device that can beused while the person goes about his daily tasks can prove to be a farbetter solution.

Previous mechanical efforts to support the cervical spine or applytraction thereto have generally fallen into certain distinct designcategories.

One such category includes cervical collars that incorporate single ormultiple, stacked pneumatic/air bladders. These devices are shown atinter alia, U.S. Pat. No. 6,050,965; U.S. Pat. No. 7,048,705; U.S. Pat.No. 5,752,927; U.S. Pat. No. 3,765,412; U.S. Pat. No. 6,0595,48; U.S.Pat. No. 6,899,690; U.S. Pat. No. 6,447,468; U.S. Pat. No. 5,916,185;U.S. Pat. No. 5,454,781; U.S. Pat. No. 5,441,479; U.S. Pat. No.5,569,176; and U.S. Pat. No. 3,343,532. Cervical collars incorporatingmultiple, stacked, fluid-filled bladders are shown at, inter alia, U.S.Pat. No. 5,823,982; and U.S. Pat. No. 5,403,266. The solid nature of theabove mentioned collars makes such apparatus difficult for a patient touse while engaging in other activities. Furthermore, the use of fluid orair filled bladders typically renders the prior art devices non-durablethereby impeding a user from participating in various common activitiesduring traction therapy.

A full, but open, cervical collar, attached to a heavy chest/backapron/harness by adjustable spring-loaded rods is shown in U.S. Pat. No.6,045,522; whereas U.S. Pat. No. 3,776,224 shows a similarspring-tensioned device. Such devices again disrupt a patient's abilityto engage in normal activities while wearing the device as well asrequire physician or other professional operation.

U.S. Pat. No. 2,102,069 shows spaced pads carried by independent sidebraces that are angularly adjustable and are also longitudinaladjustable via sliding members and clamping screws. Threaded rodadjusters are shown in U.S. Pat. No. 2,736,314; U.S. Pat. No. 2,820,455;and U.S. Pat. No. 3,177,869. U.S. Pat. No. 5,046,490 places a peg in ahole on a sliding bar to fix the length and employs a hinge mechanism tocontrol abduction in one embodiment and, in another, uses nuts on athreaded rod to cause a collar to slide up and down.

A rack and pinion system is shown in U.S. Pat. No. 2,791,999. A halo toskull fixation device is attached to shoulder harness by calibratedthreaded rods in U.S. Pat. No. 5,195,947 and in U.S. Pat. No. 5,697,894.

A full collar with a tracheal core aperture designed for static supportand emergency immobilization is shown in U.S. Pat. No. 4,886,052 and afull collar with a ratchet and pawl mechanism for improved fit,emergency immobilization is shown in U.S. Pat. No. 6,036,664.

U.S. Pat. No. 5,651,754 illustrates a device for reforming the spinewhich utilizes a belt that is tightened about the waist and amotor-driven vertical rod that spaces a brace that engages the arm pitsor the chin.

U.S. Pat. No. 6,875,189 to Nelson shows a cervical traction device whichutilizes, inter alia, a hinge to attach the occipital support to themain body. U.S. Pat. No. 6,599,257 illustrates a cervical therapy devicewhich allows rotation about two perpendicular axes and linear movementalong one of these axes.

Despite the breadth of the foregoing variations, there is a need forimproved apparatus and methodology for traction-based therapy. Suchimproved apparatus and methodology would ideally provide a patient witha user-friendly, simple, lightweight, easily installed and easilyadjusted device which allows the application of appropriate, effectiveand efficient cervical traction by the patient in any setting; e.g.,while the patient is an upright, mobile position, or while stillpermitting continuous passive motion by the patient (such as e.g.,allowing them to rotate their head to either side).

Such apparatus and methods would furthermore advantageously implementdata collection and transmission elements, as well as be adapted toprovide a physician, physical therapist, chiropractor or otherhealthcare provider (or even the patient themselves) with the ability toprogram in the apparatus a regimen for the patient to follow, as well asincorporate monitoring functionality for the healthcare provider.

SUMMARY OF THE INVENTION

The present invention satisfies the foregoing needs by providing, interalia, a device which is capable of providing both cervical spine supportas a brace and adjustable symmetric and asymmetric cervical spinetraction in an entirely portable fashion. It may be electronically ormanually controlled, and is adapted to record information regarding apatient's use of the apparatus for later analysis.

In a first aspect of the invention, traction apparatus is disclosed. Inone embodiment, the apparatus comprises: a collar member, and a headmember, the head member being mated to the collar member such that thehead member can rotate relative to the collar member around a firstaxis, yet not move substantially in a direction longitudinal along theaxis. The rotation allows the head of a wearer of the apparatus torotate, yet substantially maintains a prescribed degree of traction onthe spine thereof.

In a second embodiment, the traction apparatus comprises: a collarmember adapted to mate with the collar region of a human being; a headmember, the head member being mated to the collar member in asubstantially rotatable relationship; at least one sensor; and datastorage apparatus, the data storage apparatus adapted to store datagenerated by the at least one sensor for subsequent use.

In one variant, the at least one sensor comprises a force or strainsensor.

In another variant, the at least one sensor comprises an accelerometer.

In yet another variant, the at least one sensor comprises a rotation orposition sensor adapted to sense the relative position of the collarmember and the head member.

In a further variant, the apparatus further comprises a networkinterface adapted to transmit the data from the apparatus to a remotelocation over a network. The network comprises e.g., a wireless localarea network (LAN).

In still another variant, the apparatus further comprises a processorand computer program adapted to run thereon, the computer program beingconfigured to monitor the at least one sensor and generate an alarmcondition if one or more prescribed criteria are violated while the useris wearing the apparatus.

In yet another variant, the apparatus further comprises a forceadjustment mechanism; and a processor and computer program adapted torun thereon, the computer program being configured to cause adjustmentof the force adjustment mechanism. Adjustment of the mechanism isperformed in one case in response to a command issued from a remotelylocated computerized device.

In a second aspect of the invention, a cervical spine brace and tractionapparatus is disclosed. In one embodiment, the apparatus comprises (i) acollar member being forwardly opening and being further comprised of apair of lateral wall sections, the wall sections each having a laterallyextending bracket and an inter-engaging means adapted to maintainalignment of the walls with respect to one another, a region adapted torest on the shoulders of a wearer, and a landing inlet adapted toreceive a protruding tab of a head brace member; (ii) a head bracemember being forwardly opening and being further comprised of aprotruding tab adapted to be received within the landing inlet of thecollar member, and a head support region contoured to fit against theoccipital region of the head of the wearer; (iii) a microprocessoradapted to store data, run at least one computer application, andtransmit the stored data; and (iv) a traction adjustment membercomprising at least one sensor adapted to transmit sensed data to amicroprocessor; at least one upwardly extending, rotatable rod mechanismsupported by each of the brackets, the rod mechanism having a pair ofcoaxial right-handed and left-handed lead screw surfaces. According tothis embodiment, traction may be applied to the cervical spine of thewearer by causing the head brace to be smoothly raised above the collarmember or in a desired position.

In one variant, the head brace member extends forwardly from theoccipital support region to a pair of regions which support eachmandible of the wearer at its normal angle.

In another variant, the at least one sensor comprises at least oneaccelerometer. In yet another embodiment, the at least one sensorcomprises at least one force gauge. In another embodiment, the at leastone sensor comprises at least one timer function.

In yet another variant, each of the brackets includes a mating threadedportion interconnected with one of the lead screw surfaces. In onevariant, the traction adjustment member further comprises a unit inwhich a miter gear is rotatably mounted to engage a cooperative mitergear which is affixed as part of the rod mechanism. In another variant,the traction adjustment member further comprises a finger-manipulableadjustor connected to a shaft for rotating the miter gear and whereinthe unit is supported from the rod mechanism. In yet another variant,each rod mechanism includes stop means associated with at least one leadscrew surface for limiting the extent to which the spacing between thecollar member and the head brace can be extended. In another variant,the microprocessor is further adapted to control the function of anelectronic control mechanism, the electronic control mechanism isadopted to control an electronic motor, and the electronic motor isadapted to electronically turn the miter gear.

In still another variant, the at least one computer applicationcomprises a therapy program, the therapy program causing themicroprocessor to receive and implement program criteria via theelectronic control mechanism. In another variant, the program criteriacomprises at least one of the maximum and/or minimum duration of use,the maximum and/or minimum force of distraction, the maximum and/orminimum extent of distraction, and the maximum and/or minimum degree ofrotation. In another variant, the apparatus further comprises an alarmor signal, the alarm or signal adapted to be triggered by a breach ofany one of the program criteria. In one option, the alarm or signalcomprises a multi-colored LED light; in another option, the alarm orsignal comprises an audible signal and in a final option, the alarm orsignal comprises a reminder, the reminder comprising an electronicmessage.

In yet a further variant, the program criteria are stored on themicroprocessor.

In yet another variant, the apparatus further comprises a user interfacewherein the program criteria are entered by a user.

In another variant, the stored data stored comprises data regarding atleast one of: the degree of rotation of the head brace member, the forceof distraction, the extent of distraction, and the duration of use. Inone variant, the stored data is transmitted to a remote device. Theremote device may comprise a device registered with a databaseassociated with the apparatus; the transmission may be wireless; and thereceiving device may comprise a personal computer.

In still another variant, the inter-engaging means comprises at leastone vertical slot on one of the lateral wall sections, and at least oneelongated lug on the other of the lateral wall sections, the elongatedlug slidably received in the vertical slot.

In a further variant, at least one of the head brace member protrudingtab and the collar member landing inlet is coated in a friction reducingagent. In one variant, the friction reducing agent comprises Teflon.

In yet another variant, the collar member further comprises anadjustable Velcro strap adapted to secure the collar member on thewearer's shoulders. Another variant has the head brace member furthercomprised of an adjustable Velcro strap adapted to secure the head bracemember on the wearer's head.

In another variant, the head support region contoured to fit against theoccipital region of the head of the wearer further comprises conformingpads. Another variant has the lateral region adapted to rest on theshoulders of the wearer further comprised of conforming pads.

In a third aspect of the invention, a cervical spine brace and tractionapparatus is disclosed. In one embodiment, the apparatus comprises (i) acollar member being forwardly opening and comprised of a pair of lateralwall sections, the wall sections each having a laterally extendingbracket and an inter-engaging means adapted to maintain alignment of thewalls with respect to one another, a region adapted to rest on theshoulders of a wearer, and a landing inlet adapted to receive aprotruding tab of a head brace member; (ii) a head brace member beingforwardly opening and comprised of a protruding tab adapted to bereceived within the landing inlet of the collar member, and a headsupport region contoured to fit against the occipital region of the headof the wearer; (iii) a microprocessor adapted to store data, run atleast one computer application, and transmit the stored data; and (iv)an electronically controlled traction adjustment member comprising atleast one sensor adapted to transmit sensed data to the microprocessor;at least one upwardly extending, rotatable rod mechanism supported byeach of the brackets, the rod mechanism having a pair of coaxialright-handed and left-handed lead screw surfaces, a motor device adaptedto control rotation of the rotatable rod mechanism, and an electroniccontrol mechanism in electronic communication with the microprocessorand being adapted to control the function of the motor device; whereintraction may be applied to the cervical spine of the wearer by causingthe head brace to be smoothly raised above the collar member or in adesired position.

In a fourth aspect of the invention, a method of using a cervical spinebrace and traction apparatus is disclosed. In one embodiment, the methodcomprises disposing the apparatus on a subject; adjusting distraction ofthe apparatus; recording adjustment data; and transmitting theadjustment data.

In one variant, the act of adjusting distraction of the apparatuscomprises manual adjustment of the apparatus. In one variation, themanual adjustment is accomplished by rotation of a starwheel. In yetanother variant, the manual adjustment further comprises the placementof stopping mechanisms on an adjustment mechanism so as to create amaximum and/or minimum permissible distraction.

In another variant, the act of adjusting distraction of the apparatuscomprises electronic adjustment of the apparatus. In yet anothervariant, the electronic adjustment is accomplished via an electroniccontrol mechanism adapted to control a motorized distraction adjustmentmechanism.

In yet another variant, the method further comprises running a computerapplication adapted to cause a microprocessor on the apparatus toreceive and implement program criteria. In yet another variant, theprogram criteria is entered by a user, the program criteria comprisingat least one of: the maximum and/or minimum duration of use, the maximumand/or minimum force of distraction, the maximum and/or minimum extentof distraction, and the maximum and/or minimum degree of rotation. Inanother variation, the method further comprises triggering an alarm orsignal if the entered criteria are not met, the alarm or signalcomprising at least one of illumination of a multi-colored LED light,triggering of an audible signal, or sending an electronic message.

In still another variant, the program criteria is selected among storedprogram criteria on the microprocessor; the program criteria comprisingat least one of the maximum and/or minimum duration of use, the maximumand/or minimum force of distraction, the maximum and/or minimum extentof distraction, and the maximum and/or minimum degree of rotation. Inanother variation, the method further comprises triggering an alarm orsignal if the selected criteria are not met, the alarm or signalcomprising at least one of illumination of a multi-colored LED light,triggering of an audible signal, or sending an electronic message.

In another variant, the recorded adjustment data comprises at least oneof duration of use, degree of rotation, force of distraction, or extentof distraction. In one variant, the adjustment data is recorded to aninternal storage device. In another variant, the adjustment data istransmitted to a remote device. In yet another variant, the remotedevice comprises a device registered with a database associated with theapparatus. The transmission may also be wireless in one variant. And, inanother variant, the registered remote device comprises a personalcomputer, the personal computer adapted to receive the adjustment data.

In a fifth aspect of the invention, a system for the use and analysis ofa traction-based therapy is disclosed. In one embodiment, the systemcomprises a cervical spine brace and traction apparatus adapted toperform traction-based therapy; a recording element, the recordingelement adapted to record adjustment data from the traction-basedtherapy; a transmitting element, the transmitting element being adaptedto transmit the adjustment data to a receiving device; a receivingdevice, the device being adapted to receive the adjustment data; and ananalysis mechanism, the analysis mechanism adapted to run on thereceiving device and to analyze the received adjustment data.

In one variant, the cervical spine brace and traction apparatus adaptedto perform traction-based therapy further comprises a manuallyadjustable traction mechanism.

In one variant, the cervical spine brace and traction apparatus adaptedto perform traction-based therapy further comprises an electronicallyadjustable traction mechanism adapted to perform at least one programmedtraction therapy program, the program stored on a microprocessor on theapparatus.

In yet another variant, the cervical spine brace and traction apparatusadapted to perform traction-based therapy further comprises anelectronically adjustable traction mechanism adapted to receive andimplement a traction therapy program, the traction therapy programcomprising user-entered program criteria, the criteria entered into amicroprocessor on the apparatus adapted to control the traction of theapparatus.

In yet another variant, the program criteria comprise at least one ofthe maximum and/or minimum duration of use, the maximum and/or minimumforce of distraction, the maximum and/or minimum extent of distraction,the maximum and/or minimum degree of rotation.

In yet another variant, the adjustment data comprises at least one ofduration of use, degree of rotation, force of distraction, or extent ofdistraction.

In yet another variant, the recording element comprises an externalstorage device in electronic communication with the apparatus.

In yet another variant, the recording element comprises an internalstorage device.

In another embodiment, the transmitting element comprises a wiredconnection to the receiving device. Alternatively, in anotherembodiment, the transmitting element comprises a wireless connection tothe receiving device. In one variant, the receiving device isauthenticated by registration with a registration database. In yetanother variant, the receiving device comprises a personal computer, andin yet another variant, the analysis mechanism comprises a computerapplication running on the personal computer.

In a sixth aspect of the invention, a system for the utilization oftraction-based therapy is given. In one embodiment, the system comprisesa means for applying traction to the cervical spine of a subject; ameans for recording adjustment data from the application of traction;

a means for transmitting the adjustment data to a receiving device; ameans for receiving the adjustment data; and a means for analyzing theadjustment data.

In one variant, the means for applying traction to the cervical spine ofa subject is accomplished via a manually adjustable traction mechanism.

In yet another variant, the means for applying traction to the cervicalspine of a subject is accomplished via an electronically adjustabletraction mechanism adapted to perform at least one programmed tractiontherapy program, the program stored on a microprocessor.

In yet another variant, the means for applying traction to the cervicalspine of a subject is accomplished via an electronically adjustabletraction mechanism adapted to receive and implement user-entered programcriteria, the criteria entered into a microprocessor adapted to controlthe adjustment of traction. In one variant, the user-entered programcriteria comprise at least one of the maximum and/or minimum duration ofuse, the maximum and/or minimum force of distraction, the maximum and/orminimum extent of distraction, and the maximum and/or minimum degree ofrotation.

In yet another variant, the adjustment data comprises at least one ofduration of use, degree of rotation, force of distraction, or extent ofdistraction.

In still another variant, the means for recording comprises an externalstorage device in electronic communication with the apparatus. Inanother variant, the means for recording comprises an internal storagedevice.

In another variant, the means for transmitting comprises a wiredconnection to the means for receiving. In on variant, the means fortransmitting comprises a wireless connection to the receiving device.

In a further variant, the means for receiving is authenticated byregistration with a registration database. In one variation, the meansfor receiving comprises a personal computer. In yet another variant, themeans for analyzing comprises a computer application running on themeans for receiving.

In a seventh aspect of the invention, a computer readable apparatus isdisclosed. In one embodiment, the apparatus comprises a storage mediumadapted to store a computer program adapted to run on a personal deviceand to receive and display adjustment data from a cervical spine braceand traction device; compare the adjustment data to pre-programmedstandards; track a user's progress with regard to pre-programmedstandards; make recommendations regarding enhancement of a user'straction-based therapy progress; and transmit periodic updates to a setof pre-determined locations.

In one variant, the personal device comprises any one of a personalcomputer, a PDA device, or a web-enabled digital telephone.

In yet another variant, the adjustment data comprises data regarding atleast one of: the degree of rotation of the cervical spine brace andtraction device, the force of distraction of the cervical spine braceand traction device, the extent of distraction of the cervical brace andtraction device, or the duration of use of the cervical spine brace andtraction device.

In yet another variant, the pre-programmed standards comprise standardsentered by a healthcare provider prior to use.

In yet another variant, the pre-determined locations comprise IPaddresses of previously registered devices.

In another embodiment, the apparatus comprises a storage medium adaptedto store a computer program adapted to run on a microprocessor incommunication with a cervical spine brace and traction device and toenable a user to enter identifying information; enable a user to enterprogram specifications to create a therapy program; alert a user whencertain program specifications are breached; and transmit periodicupdates to a set of predetermined locations.

In one variant, the microprocessor comprises a microprocessor locatedwithin a cervical spine brace and traction device.

In yet another variant, the program specifications comprise at least oneof the maximum and/or minimum duration of use, the maximum and/orminimum force of distraction, the maximum and/or minimum extent ofdistraction, the maximum and/or minimum degree of rotation.

In yet another variant, the pre-determined locations comprise IPaddresses of previously registered devices.

In a ninth aspect of the invention, traction apparatus is disclosed. Inone embodiment, the apparatus comprises: a collar apparatus adapted tomate with the collar region of a subject; a head support apparatus, thehead support apparatus being mated to the collar apparatus byassociation through at least one substantially adjustable supportmember, the at least one support member comprising at least onemechanism for moving the head support apparatus relative to the collarapparatus so as to increase or decrease the traction applied to a user.

In one variant, the at least one substantially adjustable support membercomprises a single substantially vertical beam.

In another variant, the apparatus further comprises: at least onesensor; and a data storage apparatus, the data storage apparatus adaptedto store data generated by the at least one sensor.

In yet another variant, the head support apparatus comprises first andsecond elements, the first element adapted to rotate relative to thesecond element around a first axis, yet not move substantially in adirection longitudinal along the axis. The first axis is substantiallyparallel and coincident with a spinal column of the user for example.The head support apparatus can also be made to rotate relative to thecollar apparatus around a second axis.

In still another variant, the rotation allows the head of the user torotate, yet substantially maintains a prescribed degree of traction onthe spine thereof.

In a further variant, the at least one sensor comprises a force orstrain sensor. Alternatively, the sensor comprises an accelerometer. Asyet another alternative, the at least one sensor comprises a rotation orposition sensor adapted to sense the relative position of the first andsecond elements of the head support apparatus.

In another variant, the apparatus further comprise a network interfaceadapted to transmit the data from the apparatus to a remote locationover a network, such as e.g., a WLAN interface.

The apparatus further comprises a processor and computer program adaptedto run thereon, the computer program being configured to monitor the atleast one sensor and generate an alarm condition if one or moreprescribed criteria are violated while the user is wearing theapparatus.

In still a further variant, the apparatus further comprises: a forceadjustment mechanism; and a processor and computer program adapted torun thereon, the computer program being configured to cause adjustmentof the force adjustment mechanism. The adjustment of the mechanism isperformed in response to a command issued from a remotely locatedcomputerized device.

These and other features of the invention will become apparent from thefollowing description of the invention, taken in conjunction with theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of one exemplary embodiment of a tractiondevice according to the present invention.

FIG. 2 is a perspective view of the collar member of the exemplarytraction device of FIG. 1.

FIG. 3 is a perspective view of the head brace of the exemplary tractiondevice of FIG. 1.

FIG. 3 a is a front elevation view of the head brace of FIG. 3.

FIG. 4 is a partial sectional view of the of the exemplary tractiondevice of FIG. 1, illustrating the interaction between the landingfeature of the collar member and the protrusion of the head brace.

FIG. 5 is a cutaway perspective view one embodiment of the tractionfeature of the exemplary traction device of FIG. 1.

FIG. 6 is a side elevation view of a second exemplary embodiment of thetraction device according to the present invention disposed on a humansubject.

FIG. 6 a is a rear perspective view of the traction device of FIG. 6,showing the advantageous axes of rotation of the present embodiment.

FIG. 6 b is a perspective view of the head brace of the traction deviceof FIG. 6.

FIG. 6 c is a cutaway perspective view of one embodiment of the tractionfeature of the exemplary traction device of FIG. 6.

FIG. 6 d is a side elevation view of an exemplary embodiment of thetraction device of FIG. 6 adapted to permit adjustment of the angularrelationship of the head of a wearer to the device.

FIG. 6 e is a side elevation view of an exemplary lockable hingingmechanism for use with the traction device of FIG. 6 d.

FIG. 7 is functional block diagram illustrating an exemplary electronicsarchitecture according to the invention, including a microprocessor incommunication with the control mechanism and patient/physician device.

FIG. 8 is a logical flow diagram illustrating one exemplary method ofusing a traction device in accordance with the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Reference is now made to the drawings wherein like numerals refer tolike parts throughout.

As used herein, the term “application” refers generally to a unit ofexecutable software that implements a certain functionality or theme.The themes of applications vary broadly across any number of disciplinesand functions (such as content management, e-commerce transactions,brokerage transactions, home entertainment, calculator etc.), and oneapplication may have more than one theme. The unit of executablesoftware generally runs in a predetermined environment; for example, theunit could comprise a downloadable Java Xlet™ that runs within theJavaTV™ environment.

As used herein, the terms “cervical” and “cervical vertebrae” pertain tothose vertebrae immediately caudual to (or behind) the skull in a humansubject.

The term “component” in the context of software refers generally to aunit or portion of executable software that is based on a related set offunctionalities. For example, a component could be a single class inJava™ or C++. Similarly, the term “module” refers generally to a looselycoupled yet functionally related set of components.

As used herein, the term “computer program” is meant to include anysequence or human or machine cognizable steps which perform a function.Such program may be rendered in virtually any programming language orenvironment including, for example, C/C++, Fortran, COBOL, PASCAL,assembly language, markup languages (e.g., HTML, SGML, XML, VoXML), andthe like, as well as object-oriented environments such as the CommonObject Request Broker Architecture (CORBA), Java™ (including J2ME, JavaBeans, etc.) and the like.

As used herein the terms “distraction” and “distracted” are intended torefer to without limitation the application of forces to a subject'sskeletal system, e.g. the vertebral column. The application of forcesmay include, but is not limited to, vertebral traction and vertebraldecompression.

As used herein, the term “integrated circuit (IC)” refers to any type ofdevice having any level of integration (including without limitationULSI, VLSI, and LSI) and irrespective of process or base materials(including, without limitation Si, SiGe, CMOS and GaAs). ICs mayinclude, for example, memory devices (e.g., DRAM, SRAM, DDRAM,EEPROM/Flash, ROM), digital processors, SoC devices, FPGAs, ASICs, ADCs,DACs, transceivers, memory controllers, and other devices, as well asany combinations thereof.

As used herein, the term “memory” includes any type of integratedcircuit or other storage device adapted for storing digital dataincluding, without limitation, ROM. PROM, EEPROM, DRAM, SDRAM, DDR/2SDRAM, EDO/FPMS, RLDRAM, SRAM, “flash” memory (e.g., NAND/NOR), andPSRAM.

As used herein, the terms “microprocessor” and “digital processor” aremeant generally to include all types of digital processing devicesincluding, without limitation, digital signal processors (DSPs), reducedinstruction set computers (RISC), general-purpose (CISC) processors,microprocessors, gate arrays (e.g., FPGAs), PLDs, reconfigurable computefabrics (RCFs), array processors, secure microprocessors, andapplication-specific integrated circuits (ASICs). Such digitalprocessors may be contained on a single unitary IC die, or distributedacross multiple components.

As used herein, the term “network interface” refers to any signal, data,or software interface with a component, network or process including,without limitation, those of the Firewire (e.g., FW400, FW800, etc.),USB (e.g., USB2), Ethernet (e.g., 10/100, 10/100/1000 (GigabitEthernet), 10-Gig-E, etc.), MoCA, Serial ATA (e.g., SATA, e-SATA,SATAII), Ultra-ATA/DMA, Coaxsys (e.g., TVnet™), radio frequency tuner(e.g., in-band or OOB, cable modem, etc.), WiFi (802.11 a,b,g,n), WiMAX(802.16), PAN (802.15), or IrDA families.

As used herein, the term “pneumatic” refers generally to any apparatusmoved or worked on by a pressurized gaseous medium (e.g. air, nitrogen,etc.), or otherwise comprising gas filled cavities.

As used herein, the term “traction” is meant to include any of the setof mechanisms for straightening broken bones or relieving pressure onthe skeletal system through the application of a longitudinal force tothe axis of the spinal column, such that parts of the spinal column arepulled in opposite directions from one another in order to stabilize orchange the position of damage aspects of the spine.

As used herein, the term “user interface” refers to, without limitation,any visual, graphical, tactile, audible, sensory, or other means ofproviding information to and/or receiving information from a user orother entity.

As used herein, the term “wireless” includes, but is not limited to,IS-95, CDMA2000, Wideband CDMA (WCDMA), Bluetooth™, IrDA interface, IEEEStd. 802.11 (a) or (g), Wireless Application Protocol (WAP), GPRS, GSM,TDMA (e.g., IS-54 or 136), UMTS, third-generation or “3G” systems suchas 3GPP and 3GPP2, ultrawideband (UWB) systems such as TM-UWB or 802.15,WiMAX, satellite systems, or any other of myriad data communicationsystems and protocols well known to those of skill in the communicationsarts.

Overview

In one fundamental aspect, the present invention comprises a cervicalspine brace and traction apparatus, and associated methods for usethereof. The apparatus incorporates a forwardly-open head and jaw bracewith adjustable supports. Another salient aspect of the presentinvention is the mating of the brace and collar members of theapparatus. Specifically, in one embodiment these components are adaptedto mate such that the brace is received within a landing inlet of thecollar member. This inlet advantageously permits the brace to rotate tothe subject's left and right (while remaining planar to the collarmember), thereby permitting the subject wearing the apparatus to have asignificant range of motion for his/her head.

Another aspect of the present invention relates to the creation oftraction via cooperating lateral walls of the collar member. The lateralwall sections of the exemplary embodiment have mating arcuate surfacesthat are juxtaposed and which include inter-engaging features thatassure they remain precisely aligned with each other with respect toangle while the vertical spacing between them is being changed, i.e.traction. A rotatable rod mechanism having screw surfaces which pairwith the threads of pairs of brackets extending laterally from each wallsection creates the traction mechanism in one variant. A miter gearaffixed to each rod in a central location mates with a cooperative mitergear affixed to a horizontal shaft that permits smooth and accuratepatient adjustment. Adjustment may also be accomplished via anelectronic motor or other electromechanical device controlled by e.g., acontrol mechanism and integrated circuit (e.g., microprocessor ormicrocontroller). The exemplary integrated circuit may be adapted tostore information regarding a user's sessions, and optionally facilitatecommunication with patient and physician personal devices, thus sendingthese data from recorded sessions. The integrated circuit may also beadapted to implement therapy sessions based on heath care providerentered program specifications, or based on e.g., pre-programmedspecifications.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

Referring now to FIGS. 1-7, exemplary embodiments and aspects of theinvention are described in detail.

It is noted that while the invention is described herein primarily interms of a method and apparatus for monitoring the use of a cervicalbrace such as during traction therapy, the invention may also be readilyembodied or adapted to monitor other prescribed therapies at otherlocations on the human body including, but not limited to, thoracic andlumbar vertebrae, as well as monitoring the use of a cervical brace suchas during traction therapy on other warm-blooded species. All suchadaptations and alternate embodiments are readily implemented by thoseof ordinary skill in the relevant arts, and are considered to fallwithin the scope of the claims appended hereto.

It is further noted that, although the description below relates toplacement of the traction apparatus on the neck and head of a subjectthereby causing distraction of the cervical spine in order to relievecervical radiculopathy; the traction apparatus described herein maylikewise be employed in other medical processes including, inter alia,osteodistraction or distraction osteogenesis. Further, the apparatusdescribed may be readily formed or shaped to accommodate other parts ofthe body, while still maintaining the advantageous features describedherein, so as to distract the bones associated therewith for the purposeof either osteogenesis and/or relief from radiculopathetic conditions.

It is likewise appreciated that the traction apparatus of the presentinvention may also be advantageously adapted for use on subjects ofvarious other species.

Apparatus for Traction-Based Therapy

FIG. 1 depicts one embodiment of the traction device 11 of the presentinvention. As illustrated, the device 11 generally comprises anadjustable collar member 15 and a rotatable head brace 13 which fitswithin the collar member 15. The traction device 11 provides cervicalspinal bracing and/or traction by exerting stretching force between theshoulders and a head brace 13 that is in contact with the occipitalregion of the head and extends forwardly (anteriorly) to support theangle and body of the mandibulae on each lateral side of the head.

Collar Member

The collar member 15 of the traction device 11 is best illustrated inFIG. 2. The collar member 15 is advantageously forwardly open whilebeing a continuous closed curve in the rear. The rear of the collarmember 15 is also relatively narrow so as to permit a gap between theapparatus and rear portion of a subject's neck. This not only permitseasy installation by the patient or wearer, but it facilitates ancillarytreatment to allow concurrent therapy, as by the application of heat orcold to relieve pain or treatment with specific neuromuscular electricalstimulation, for example.

The collar member 15 is further comprised of two lateral wall sections17, 19 which extend superiorly therefrom and are arranged, shaped, andproportioned to lie in a juxtaposed relationship with regard to oneanother. Inter-engaging means are utilized between the two juxtaposedwall sections 17, 19 to assure that the collar and the head brace aremaintained in the precise alignment, i.e., angular orientation, one tothe other, while the walls 17, 19 are being moved vertically eithernearer together or further apart.

In the illustrated embodiment, the lateral wall sections 17, 19 have ashallow arcuate cross sectional shape with surfaces that havesubstantially the same radius of curvature so that the exterior surfaceof each lateral wall section 19 lies in contact with the interiorsurface of the depending lateral wall sections 17, as seen in FIG. 2. Tofacilitate this precise alignment while allowing such relative motion,the depending lateral wall sections 17 are preferably each provided withone or more parallel slots 21. In one embodiment, three slots 21 areutilized; two of which lie forward of the ear, with the third beingpositioned rear of the ear when a subject secures the apparatus to theneck. The slots 21 are preferably uniform in width throughout theirlength, and they receive parallel, rectangular guides 23 affixed to theexterior surface of each of the lateral wall sections 19 that extendsuperiorly from support region of the collar. These guides 23 areinter-engagingly, slidably received in the parallel slots 21, and thestraight sidewalls of the rectangular guides 23 lie closely adjacent theelongated walls of the slots 21 and thus assure smooth relative motionbetween two walls 17, 19 in a precise direction both vertically andangularly. Moreover, the spacing of the singular slots 21 at a rearwardlocation adds substantially to the overall stability of the spatialalignment. Once assembly is completed, small keepers 24 are affixed tothe outer surfaces of the guides 23 by pins or the like to secure theinter-engagement. It will be appreciated that other means for securingthe two walls 17, 19 to one another while maintaining smooth relativemotion may be utilized consistent with the present invention includingfor example, tracks, sliders, threads, notches or other guides. Further,it will be appreciated that the number and placement of suchinter-engaging means may be varied consistent with the present inventionso as to increase stability and/or ease of motion between the walls 17,19.

The collar member 15 further comprises a continuous curved undersurface,which is shaped and proportioned to lie comfortably on the shouldergirdle of the wearer at a location close to the base of the neck. It isconstructed of material similar to that of the head brace 13 so as topreferably aesthetically resemble each other. Ends 31 of the open collarmember 15 that terminate at the front opening are in the illustratedembodiment provided with inter-engaging Velcro straps 32. However,alternative fastening arrangements may be utilized consistent with thepresent invention so as to provide additional security and/or stability.In one embodiment (not shown), the undersurface of the collar member 15,i.e. the portion which will come into contact with a wearer's shouldersis provided with padding or cushioning material. The padding orcushioning may be comprised of a conformable substance such as air, ormemory foam pads. In an alternate embodiment, the shoulder portion ofthe collar member 15 may be advantageously molded to the individualpatient.

Head Brace

The head brace 13 of the traction device 11 is best illustrated in FIGS.3 and 3 a. The head brace 13 supports the occipital region of the headand is advantageously forwardly open while being in a continuous closedcurve in the rear and permitting a space between the apparatus andsubject's neck. As discussed above, this facilitates easy installationby the wearer as well as concurrent therapies.

The brace 13 preferably has a continuous curved or arcuate rear portion27 that is contoured to comfortably abut the occipital region of theskull and a pair of oppositely disposed forward sections 29 that arecontoured and angled to comfortably engage the undersurface of eachmandible. It is preferably molded from a lightweight polymeric material;however, other suitable durable materials may be used. In theillustrated embodiment, a pair of inter-engaging Velcro hook and loopfastening straps 30 are affixed to the exterior surfaces of these frontsections 29 so as to provide additional stability when the user ismobile; alternatively a single strap could be used that would attach toa strip affixed to the surface of the brace. The upper surface of thebrace 13 is provided with padding or cushioning material (not shown),e.g. resilient polyurethane foam, or visco-elastic polyurethane foam(i.e., memory foam).

Although the aforementioned components have been illustrated anddescribed with regard to an exemplary embodiment, it should beunderstood that the scope of the invention is defined by the claimsappended hereto and that changes and modifications as would be obviousto one having the ordinary skill in this art may be made withoutdeviating therefrom, and that such changes may enhance the overallperformance of the traction device 11. For example, although the brace13 and collar member 15 are discussed as being unitary in construction,each of them may be made in two or more pieces so as to be adjustablewith each other (not shown).

Collar/Brace Interaction

One salient aspect of the present invention is depicted in FIG. 4. Asillustrated, the collar member 15 advantageously comprises a landingfeature 10 (see also FIG. 2) adapted to receive the correspondingprotrusion 14 of the head brace 13 (see also FIG. 3). Specifically, thelanding feature 10 comprises a substantially horizontal inlet 12 havingdepth and height able to accommodate the length and height of theprotrusion 14 respectively so as to facilitate continuous passivemotion. FIG. 4 depicts the mating of the landing feature 10 of thecollar member 15 with the protrusion 14 of the head brace 13.

As depicted, it is desirable that the dimensions of the inlet 12 beroughly similar to those of the protrusion 14 so as to accommodate theprotrusion snugly and reduce tilting of the brace 13 when mated with thecollar 15. It is also noted that the landing feature 10 extendsthroughout the periphery of the collar member 15 creating a landinginlet 12 that extends across the periphery of the collar member 15 andpermitting mating of the protrusion 14 and inlet 12 around the peripheryof the collar member 15. Further, the landing feature 10 is adapted soas to permit the mated brace 13 to rotate in the direction given by 16.In one embodiment, the protrusion 14 is advantageously coated with afriction reducing coating, such as Teflon®, etc. This coating permitsunimpeded rotation of the head brace 13 about the vertical axis of theneck while maintaining the head brace 13 substantially parallel to theplane of the landing inlet 12. Thus, a patient will be permitted torotate their head in a right or left direction while the subject's neckis simultaneously distracted.

Traction Mechanism

As discussed above, the present invention also beneficially providestraction therapy to cervical vertebrae. In order to accomplish thispurpose, the apparatus comprises certain features adapted to enable thestraightening or elongation of these vertebrae with respect to oneanother. The features discussed below (and depicted in the givenfigures) are merely exemplary in nature and are not intended representthe only embodiment of the present invention; rather, a plurality ofmechanisms for accomplishing the traction function may be utilizedconsistent with the present invention.

Specifically, in one embodiment of the present invention (illustrated inFIG. 2) pairs of apertured brackets 33, 35 of generally similarconstruction which extend laterally from surfaces of the walls 17, 19 ofthe collar member are utilized. These brackets are provided to achievethe adjustment of the vertical spacing between the collar member 15 andthe brace 13 when the two are mated, as discussed above. A pair ofbrackets 33, 35 comprises one lower bracket 33 which extends from theexterior surface of the upstanding wall 19, and one upper bracket 35which extends from the exterior surfaces of the depending wall 17. It isappreciated that any number of bracket pairs may be utilized consistentwith the present invention.

Referring now to FIG. 5, a rotatable rod mechanism 39 which is supportedby and extends between the upper and lower brackets on each side of thedevice 11 is depicted. The rod mechanism 39 is designed to veryprecisely and smoothly adjust the vertical distance between the twowalls of the collar 15 so as to either apply greater traction or reducethe traction force. As discussed above, the collar 15 is adapted toreceive the head brace 13; accordingly, when the distance between thetwo walls is adjusted, the distance between that portion of the device11 engaged with the head brace 13 and that portion resting on apatient's shoulders is adjusted. The rod mechanism 39 is designed so asto balance out any torque by creating driving engagements both at thelocation of the upper bracket 35 and at the location of lower bracket 33on each side of the device, and in this way to positively avoid thelikelihood of binding and to assure smooth movement.

In the illustrated embodiment, the rod 39 is one which has an upper leadscrew surface 41 of one orientation, e.g., a right-handed thread, and alower lead screw surface 43 of the opposite orientation, e.g., aleft-handed thread. These screw threads are preferably cut into thesurface of a rod of a suitable diameter so that the rod is an integralpiece; however, the rod could be built as a composite member so long asthe resultant structure has coaxial lead screw surfaces. A centralsection 45 of the rod 39, preferably located exactly halfway from eachend, is of a reduced diameter, and it may be machined to have a mitergear surface 47, or alternatively such a gear may be affixed to thereduced diameter rod section. The upper and lower threaded sections 41,43, which are preferably located at opposite ends of the rod 39, arereceived in the apertures of the brackets 35, 33. These apertures may bemachined so as to have mating threads which inter-engage with the leadscrew surfaces 41, 43 on the upper and lower sections of the rods, orthe brackets 33, 35 may, in another embodiment (not shown), be molded soas to have hexagonal recesses in their facing surfaces into which metalnuts having mating threads are press fit and/or adhesively secured. Inan alternative embodiment, the brackets 33, 35 might be bifurcated toprovide horizontal slots into such nuts could be inserted and secured inalignment.

Accordingly, when the rod 39 is caused to be rotated clockwise as viewedfrom above, both rod threaded sections 41, 43 may enter more deeply intothe brackets 35, 33 and thus cause the two walls 17, 19 of the collarmember 15 to smoothly move toward each other, slightly reducing theamount of traction. Likewise, when the rod 39 is caused to be rotatedcounter-clockwise, both rob threaded sections 41, 43 disengage from thebrackets 35, 33 and cause the two walls 17, 19 to smoothly move awayfrom each other, thereby increasing the amount of traction.

To drive the rod mechanisms 39, a small gear box 51 is supported on eachrod at the location of the central section 45 of reduced diameter. Thegear box 51 has apertures in its upper and lower ends so that it isjournalled on the rod itself, and it is preferably a rectangularparallelepiped for convenience of construction. It contains a miter gear53 mounted on a horizontal shaft 55 that extends through the gear box 51wall which the miter gear 53 meshes smoothly with the miter gear 47affixed to the rod; thus, its rotation drives the rod 39 in eitherclockwise or counterclockwise rotation. The horizontal shaft 55 isjournalled in the gear box wall, preferably by a suitable bearing (notshown), and it carries a knob in the preferable form of a starwheel 57affixed to its outer end which the patient will use to turn the mitergears 53, 57, rotate the rod 39 and thus move the walls 17, 19 of thecollar member 15 smoothly toward each other or away from each other.

The illustrated embodiment of FIG. 2 incorporates a starwheel 57adjustment mechanism. It is appreciated, however, that the starwheel 57is exemplary in nature and that a plurality of shapes or forms ofadjustment mechanisms may be utilized consistent with the presentinvention, including, for example, a scissor mechanism, step-upmechanism, buckles, etc. Further, the adjustment mechanism (including astarwheel 57) may be located in a plurality of positions relative a userand any number of such mechanism may be utilized consistent with thepresent invention. The precise change that is possible in this mannerprovides a potential for objective calibration, i.e., the number ofscrew rotations needed to achieve one millimeter of distraction ofintervertebral space. This use of the two lead screw surfaces ofopposite threading and the miter gear arrangement allows for verygradual and precise changes in the spacing between the brace and thecollar member, and thus allows “fine tuning” of the amount of tractionbeing applied.

Because a physical therapist may wish to limit the amount of tractionthat any individual patient can apply at any one time duringrehabilitation, FIG. 2 further depicts a locking clamp, a locking washeror nut or other such stop 59, which is preferably provided near the endof one of the lead screw surfaces of each rod 39. Illustrated is such astop clamp 59 which is manufactured to have an interior surface thatinter-engages with the threads 41 at the upper end of the rod. It mightbe molded from a rigid plastic or preferably made of metal; it isdesigned to snap around the threaded rod and remain tightly in oneplace. A short tang extends from a central location to allow its easyplacement or removal. Thus, it allows the physical therapist to set amaximum distance to which the brace and the collar member can be spacedapart, so that, when such distance is reached, the lock clamp 59 willengage top surface of the upper bracket 35, for example, preventing anyfurther rotation of the rod by the patient that would tend to drive thebrackets 33 and 35 further apart. This lock 59 may, if desired, beconstructed so that it can only be moved or removed via the use of aspecial tool, so that is must otherwise remain in the precise locationwhere the physical therapist has set it. For example, the two open endsmay be linked to each other by a clamping screw which has a headdesigned to require a special tool to allow it to be tightened andloosened.

Referring back again to FIG. 5, in an alternative embodiment, theadjustment of the device 11 may be accomplished electronically (ratherthan manually). Accordingly, the gear box 51 is adapted to include atleast one electric motor device 65, such as, for example, that shown inU.S. Pat. No. 5,651,764 incorporated herein by reference in itsentirety, which would be employed to drive the miter gear 53 in either aclockwise or counterclockwise direction as well as stopping. Such anelectric motor drive mechanism 65 may be operated by a hand-held orbelt-supported finger-operated push-button controller (not shown) thatmight be connected through a wired and/or wireless electronic connectionto a controller 67 mounted, for example, on the motor 65 or incorporatedinto a separate component (not shown). Alternatively, a voice-activatedcontroller could alternatively be incorporated as a part of the motordrive. As discussed in greater detail below, the controller 67 mountedon the motor 65 may be adapted to store information relating to theduration of use, distraction, and degree of rotation. The controller 67may also be programmable by a medical service provider so as to ensurethat the patient complies with a particular traction therapy regimen.

Traction will gradually increase the spacing between a patient'svertebrae, and damaged cartilage and tissue between the vertebrae thenmay often swell to fill this space. When this occurs, should tractionsubsequently be removed too quickly, the swollen tissue between thevertebrae will often be pinched and cause severe pain. Thus, to avoidthis potential problem, one should remove traction at a slow andcomfortable rate. This is made possible by the unique design of coaxiallead screw surfaces that can be simultaneously and precisely rotatedthrough miter gear drives conveniently accessible to the patient; or,alternatively, by a step-down mechanism in an electronically controlleddevice 11. This particular adjustment mechanism not only allows apatient to make a quick and easy reduction in the amount of traction torelieve nausea, should any unexpected difficulty be encountered whenincreasing traction, but also the beneficial combination of the mitergear arrangements with the pairs of coaxial lead screw surfacesfacilitates, the release of traction at any time in a carefullycontrolled manner so the patient should be safe from tissue damage.Moreover, both symmetric and asymmetric traction are readilyfacilitated.

Because the device does not involve any shoulder girdle, chest harnessor cranial fixation, the torso remains free, contributing to theportable/unencumbered nature of the device, while promoting auser-friendly design. The design of the device avoids any pressure onthe mental process or chin, thus eliminating a potential physiologicreflex arc which might involve stimulation of the vagus nerve in theneck, the stimulation of which is often associated with unpleasantnausea and potentially dangerous heart rate reduction. In embodiments,where the device is molded of a plastic material, suitable plasticmaterials which are radiolucent can be chosen so that the user maycontinue wearing the brace even when undergoing radiographic studies,and in some instances, such a construction may also enhance the use ofx-rays.

Rear Column Embodiment

FIG. 6 depicts a second exemplary embodiment of the traction device 91of the present invention; the illustrated embodiment depicts the device91 disposed on a human subject about the subject's neck. As illustrated,the device 91 generally comprises an adjustable single column supportmember 92 and a rotatable head brace 94. The traction device 91 providescervical spinal bracing and/or traction by exerting stretching forcebetween the shoulders and a head brace 94 that is in contact with theoccipital region of the head and extends forwardly (anteriorly) tosupport the angle and body of the mandibulae on each lateral side of thehead. Thus, while traction is applied, the user's head is fullysupported.

As illustrated by FIG. 6 a, the head brace 94 of the present embodimentinteracts with the upper circular structure 98 of the support member 92.The precise interaction will be discussed in detail below (see FIG. 6c).

Also illustrated in FIG. 6 a, the support member 92 advantageouslycomprises an upper circular structure 98, a lower collar brace 99 and asingle columnar, adjustable support 93. It is appreciated by the figurethat both the head brace 94 and lower collar brace 99 of the presentembodiment are forwardly opening. The ends of the open head brace 94 andcollar brace 99 that terminate at the front openings are, in theillustrated embodiment, provided with inter-engaging Velcro straps 102.However, alternative fastening arrangements may be utilized consistentwith the present invention so as to provide additional security and/orstability. Further, in one embodiment (not shown), the undersurface ofthe collar brace 99 (i.e. the portion which will come into contact witha wearer's shoulders) and/or the upper surface of the head brace 94(i.e. that portion which will come into contact with the wearer's neckand chin) are provided with padding or cushioning material. The paddingor cushioning may be comprised of a conformable substance such as air,or memory foam pads. In an alternate embodiment, the shoulder portion ofthe collar brace 99 may be advantageously molded to the individualpatient.

The columnar support 93 is disposed at the rear of the device 91 withregard to the subject's head; and further comprises an upper and lowersliding adjustment 95 and a central rod 96. The columnar support 93, asdescribed, allows for the same functionality as the lateral sidesupports created by the overlapping walls 17, 19 of the collar member 15of the previous embodiment (FIGS. 1 and 2). Specifically, the upper andlower sliding adjustments 95 are adapted to slide on the fixed centralrod 96 in a superior and inferior direction, given by 107, with respectto the subject's head. The sliding adjustments 95 slide on the centralrod 96 when the knob 97 is rotated in either direction given by 106;with one direction of rotation of the knob 97 being associated with theadjustments 95 moving closer together, and the other associated with theadjustments 95 moving farther apart. It is by this mechanism thattraction is applied to the spine of a subject (or alternatively,traction is decreased).

As discussed above, the embodiment of FIGS. 6 and 6 a may, instead of,or in conjunction with the turnable knob 97 advantageously comprise asmall gearbox (not shown) such as that of the embodiments of FIGS. 1 and2. Accordingly, the gearbox would be supported on the central rod 96 andwould work with the internal mechanics of the columnar support member 93to participate in and direct the sliding of the two sliding adjustments95. In one further embodiment, the gearbox (not shown) would beelectronically controlled by a control mechanism (not shown).

Referring back to FIG. 6 b, the traction device 92 further comprises alower collar brace 99. The lower collar brace 99 has a continuous curvedundersurface, which is shaped and proportioned to lie comfortably on theshoulder girdle of the wearer at a location close to the base of theneck. It is constructed of material similar to that of the head brace 94so as to preferably aesthetically resemble one another.

Referring now to FIG. 6 b, the head brace 94 of the present embodimentis shown. In the illustrated embodiment, the head brace 94 comprises areceiving feature 103 which is adapted to accommodate the upper circularstructure 98 of the columnar support member 93. The interaction betweenthe receiving feature 103 and circular structure 98 is best illustratedin FIG. 6 c. Accordingly, the circular structure 98 of the columnarsupport member 93 rests on the landing 104 of the receiving feature 103.In a manner generally similar to that described with respect to FIG. 4above, continuous and passive motion of the user's head is facilitated.The structure of the receiving feature 103 and circular structure 98extending about the edge of the head brace 94 enables the user to movehis/her head (e.g., rotate the head) in the direction given by 105(generally left-to-right) about the axis 101. It is noted that the forceof motion facilitated by the traction device 92 is generated by theuser, no active mechanism or device is utilized to cause the head torotate in this embodiment.

Referring back to FIG. 6 a, in yet another embodiment, the tractiondevice 92 is adapted to rotate about an axis 100 behind the wearer'shead. Rotation about this axis 100 in the direction given by element 108of FIG. 6 a enables a wearer to move his head in a generallyleft-to-right direction as discussed with regard to rotation about axis101 above; however, the axis of rotation is offset to a positiondirectly behind the user's head/neck, which may have advantages incertain applications. Rotation about this axis 100 may be accomplishedby providing, inter alia, an upper sliding adjustment 95 which isadapted to simultaneously rotate on the center rod 96 in the directionshown by element 108.

In yet another embodiment, the traction device 92 is adapted to permitrotation about both axes 100 and 101 so as to permit a wearer evengreater range of motion of the head while distracted. Allowing thedevice to articulate or rotate around two axes 100, 101 permits in somecases a more comfortable user experience and greater range of motionthan that produced by rotation about axis 100 or 101 alone. Rotationabout these axes is accomplished by incorporating both the receivingfeature 103 and circular structure 98 discussed in FIG. 6 b as well asthe rotating upper sliding adjustment 95 described above.

In another embodiment (not shown), the head brace 94 utilizes othermechanisms and features which enable the head brace 94 to rotate aboutthe aforementioned axes while still maintaining an association with theupper circular structure 98 of the traction device 92, includingutilization of roller bearings, ball bearings, fluid dynamic bearings,hydrostatic or gas bearings. In yet another embodiment, substantiallyfrictionless rotation is better facilitated by the use of rare earthcobalt magnets of the type well known in the art. In one such variant,the repulsive magnetic force of such magnets is used to provide astandoff distance between two moving surfaces, thereby substantiallyeliminating a major source of friction in such a mechanism configuredusing more conventional mechanical solutions such as sliding surfaces.

It will be appreciated that while a single rear column is illustrated inthe exemplary embodiment of FIG. 6, the invention is in no way solimited, and other numbers and columns of configurations may be used.For example, in one variant, two substantially parallel columns areused. Moreover, other non-columnar mechanisms may be used in place ofthe column illustrated in FIG. 6.

It may also be advantageous, in certain situations, for a physician orhealth care provider to be able to adjust the angular relationship ofthe head relative the shoulders of a wearer; i.e., the angle of the chinrelative to the user's chest. However, as discussed above, this angularrelationship generally must be completely fixed during the applicationof traction. Thus, in one embodiment of the present invention (see FIG.6 d), the device 92 comprises one or more lockable articulated joints orhinges 110, 113 fixedly attaching the various components of the tractiondevice 92.

The first lockable joint or hinge 110 is adapted to attach the circularsupport structure 98 to the upper sliding adjustment 95. The joint 110is placed in a manner which advantageously permits the circularstructure 98 to rotate in the direction given by 111 while still beingfixed to the upper sliding adjustment 95. In one embodiment, this isaccomplished by utilization of interlocking, toothed faces which are setinto mated cooperation with one another by a nut and bolt assemblyand/or a wingnut 112 for increased torque (see FIG. 6 e below). Myriadother approaches readily recognized by those of ordinary skill in themechanical arts may be used as well for this function (i.e., locking thetwo components rigidly in a desired orientation).

When the head brace 94 is mated with the circular structure 98, the headbrace is also able to tilt or rotate in the direction given by 111. Oncethe appropriate angular adjustment (via a healthcare provider'sinstruction for example) is accomplished, the joint at 110 will belocked into place.

The illustrated embodiment further (optionally) provides a secondlockable articulated joint or hinge 113 which is adapted to fixedlyattach the lower collar brace 99 to the columnar support 93. Theplacement of the second locking hinge 113 enables the lower collar brace99 to tilt or rotate in the direction given by 114 while still beingfixed to the lower sliding adjustment 95. Thus, when the traction device92 is worn, the lower collar brace 99 advantageously adjusts to theparticular slope of the shoulders and clavicle of the specific wearer.As above, once the lower collar brace 99 is placed comfortably on thewearer, the hinge or joint 113 may be locked into place. The lockinghinge mechanism of this embodiment may advantageously comprise the samemechanism as described above with regard to the first hinge 110, or maycomprise various other hinging or rotational joint mechanisms of thetype known in the art.

FIG. 6 e illustrates one embodiment of a hinging mechanism which may beutilized at hinges 110 and 113 of the embodiment of FIG. 6 d. The figureillustrates the interface of the various toothed faces 115 and wingnut112 assembly. As illustrated, the assembly permits a user to unscrew thewingnut 112 and rotate the circular support 98 in the direction given by111. Then, to lock the components into place, the user will align thetoothed faces 115 and re-screwed screwed the wingnut 112 into theassembly. This embodiment has the advantage of not pre-setting largeincrements by which a user may increase or decrease tilt; the range ofincrements/positions is large based on the size and number of teeth onthe toothed interfaces 115. Accordingly, locking the device 92 into acertain configuration is associated with a particular degree of angularadjustment of the head or shoulders with respect to the columnar support93. Where it is known that a particular degree of adjustment isadvantageous, the toothed interfaces 115 may be adapted to provide suchdegree as well as to inform the wearer the degree of angular adjustmentat each stop along the interfaces 115.

In another embodiment (not shown), the hinging mechanism which may beutilized at hinges 110 and 113 of the embodiment of FIG. 6 d comprises apush-button mechanism on the upper and/or lower sliding adjustment(s)95. Pressing of the push-button mechanism releases a key or lockingelement which is adapted to fit and lock within one of a plurality ofapertures disposed on the circular structure 98 and/or on the lowercollar brace 99. The apertures are disposed, therefore, in a manner soas to facilitate step-wise increased or decreased tilting of the headbrace 94 and/or collar brace 99; and, as above, may be adapted toprovide particular degrees of angular adjustment and inform the wearerof the degree associated with each aperture.

It is appreciated that various other mechanisms may be utilizedconsistent with the present invention to provide for the pivoting and/orhinging functions denoted by hinges 110, 113. It is further appreciatedthat other mechanisms may be employed to ensure that the slidingadjustments 95 will not function until the hinge(s) are locked intoplace, thus ensuring that a wearer is only able to apply traction oncethe angle is set; thus ensuring that a wearer will not be hurt or willnot misuse the traction device.

Electronic Monitoring

Another salient aspect of the invention regards the ability of thedevice 11, 92 to electronically monitor certain facets of its use. Asdiscussed above with respect to FIGS. 5 and 6A, in one embodiment thepresent invention is adapted to incorporate a control mechanism 67adapted to control an electronic motor device 65. The device 11, 92 mayalso incorporate an array of sensors within and/or on the device 11, 92.Among these sensors may be at least one accelerometer and at least oneforce gauge, and a timer function. Referring to FIG. 7, the sensors areused as inputs to a microprocessor or microcontroller 71 which can beprogrammed to read and measure the various signals from the sensors. Thechip 71 may be physically located within or on the device 11, 92, or inan alternate embodiment, located remote to the traction device 11, 92.

The control mechanism 67 may further be in communication with theaforementioned microprocessor 71. The microprocessor 71 is then adaptedto affect the functioning of the electronic motor 65 via the controlmechanism 67 (see discussion below). Further, the microprocessor 71 mayalso be in communication with (and thereby controlled and/or monitoredby) a patient and/or physician device (PPD) 75 (via a registrationprocess, discussed below); such a device may comprise for example, apersonal computer, PDA, laptop, web enabled telephone, etc. Thecommunication between the microprocessor 71 and the electronic motorcontrol mechanism 67 and/or the PPD 75 may be established via a wiredconnection, or through wireless means well known in the communicationsarts, including for example, Bluetooth, wireless LAN, etc.; othermechanisms for facilitating communication between the entities are alsocontemplated herein as well.

For security reasons, the microprocessor 71 will only be permitted tocommunicate with registered devices. Accordingly, a PPD registrationdatabase 79 is provided. Alternatively, encryption and authenticationprotocols can be used to effect such limited communications. In oneembodiment, the database 79 is “small scale” and located at the tractiondevice. It is appreciated, however, that the database may, in analternative embodiment, be maintained at other locations and be “largescale” in nature. The “small scale” nature of the given database refersto the fact that the database will only be adapted to store identifyinginformation about those PPD 75 registered to that traction device 11,92; the identifying information may include, inter alia, IP address andthe like. The “large scale” database would be adapted to store IPaddresses and/or other identifying information of many traction devices,and of many registered patient and physician (or healthcare provider)devices PPD 75. The “large scale” database would therefore act as acentral information hub.

In order to access traction data, input therapy program criteria, and/orreceive reminders, updates and alarms, patients and healthcare providersmust first establish a connection (either wired or wireless) to thedatabase 79 and register their devices. Then, when the traction device11, 92 has information to be sent (including an alarm, reminder orcollected data), or when information is requested, those registereddevices will receive the data. Further, the registered devices will beenabled to enter certain program criteria on an interface (discussedbelow) and have that criteria sent to the traction device'smicroprocessor 71 for implementation.

In one exemplary aspect, the microprocessor 71 comprises monitoring,transmission, and alert functionality, facilitated by variousapplications the microprocessor 71 is adapted to run. In someembodiments, the microprocessor 71 will also have associated storageand/or RAM 73. The microprocessor 71 and storage and/or RAM 73 arefundamental in providing certain ones of device 11, 92 function. Forexample, in one embodiment, the microprocessor 71 and associated storageand/or RAM 73 are adapted to run an application which continuously orperiodically records certain aspects of the traction device 11, 92operation or operating conditions.

As discussed above, the microprocessor 71 and associated storage and/orRAM 73 may be adapted to run various programs which will impart variousfunction to the traction device 11, 92. For example, in one embodiment,the microprocessor 71 and associated storage and/or RAM 73 are adaptedto run an application which would record and store data relating to,inter alia, the duration of use, force of distraction, extent ofdistraction, and degree of rotation. This information may then besubsequently sent to a PPD 75 for physician and/or patient evaluationand analysis, such as via a user interface (e.g., display) on the PPD.Transmission of the collected data to the PPD 75 may be accomplished viawired or wireless connection thereto. In order to transmit datawirelessly, the various PPD 75 must be registered with a PPDregistration database 79 as discussed above.

In another embodiment, the microprocessor 71 and associated storageand/or RAM 73 would be adapted to run an application which would cause asignal or alarm to detonate after a prescribed amount of time. Thisfunction would enable a patient to appreciate when sufficient time haspassed between therapy sessions and prompt the patient to begin a newsession. As with the above mentioned application, data regarding thepatient's use of (or failure to use) the device may be transmitted to aPPD 75 for physician and/or patient evaluation and analysis. Further,the application may also be adapted to cause a telephone or emailmessage to be sent to remind a patient and/or the observing physicianthat a sufficient time has passed between therapy sessions. Theconveyance of the aforementioned messages may be accomplished via thesame registration mechanism described above.

In yet another embodiment, the microprocessor 71 and associated storageand/or RAM 73 would be adapted to run a program which would present auser (preferably a physician, physical therapist, chiropractor, or otherhealthcare provider) with options so as to create a traction-basedtherapeutic treatment schedule. The user will be able to enter certaincriteria regarding the treatment schedule including, inter alia, theoverall duration of the treatment, the duration of each therapy session,the maximum degree of rotation permitted in each session, the maximumextent and force of distraction permitted in each session, the distanceof traction for each session, etc. Entering a treatment schedule will beaccomplished via an application running on the user's PPD 75. Theexemplary program would, as discussed, prompt a user (healthcareprovider) to enter criteria regarding the treatment schedule, enable theuser to enter other data or criteria, and transmit the created programto the device microprocessor 71 via the registration mechanism discussedabove. A user may thereby achieve long term treatment goals.Alternatively, the storage and/or RAM 73 may have stored pre-programmedtherapy sessions which the user (either a patient or healthcareprovider) may select and employ. Again, selection here beingaccomplished via an application running on the user's PPD 75 andselections transmitted via the previously discussed registrationmechanism. The same alarm and reminder functions discussed above may beemployed in this embodiment as well.

In addition, an input component may be utilized in some embodimentswhereby the patient can input feedback with regards to pain anddiscomfort associated with the programmed therapy sessions. In thisfashion, the observing physician can correlate higher degrees ofdiscomfort and/or pain with various measured parameters (e.g. degree ofmovement/rotation, etc.). Accordingly, the observing physician and/orpatient can modify the therapy session in accordance with objective andsubjective observed parameters. The input component may be incorporatedinto the device 11, 92 itself or may be operated externally (via e.g. aweb-based interface on a host computing device).

The microprocessor 71 and associated storage and/or RAM 73 may furtherbe adapted to run a preventative stopping program. According to thisapplication, the device 11, 92 may be set to have manually enteredand/or pre-programmed maxima and minima for the aforementioned monitoredaspects of use including without limitation, duration of use, degree ofrotation, extent and force of distraction, etc. The application may beadapted to absolutely prevent the use of the device beyond theprescribed minimum and maximum by either being adapted to stop furtherrotation of the rod mechanism (in either direction) or by being adaptedto trigger a signal or alarm when the prescribed levels are breached.

PPD Interface

As discussed above, the PPD 75 of the present invention are adapted toreceive and send information to and from the microprocessor 71 of thetraction device 11, 92. Accordingly, the PPD 75 must be adapted to runone or more computer applications having the ability to read and displayinformation from the traction device 11, 92 and to send information to atraction device 11, 92 in a form the microprocessor 71 of the tractiondevice 11, 92 can understand.

Accordingly, the present invention appreciates a computer programrunning on the physician (or healthcare provider) PPD 75. This programwill enable the healthcare provider to extract data from the deviceregarding duration of use, force and extent of distraction, degree ofrotation, etc. The program would also advantageously provide thehealthcare provider with the ability to trend and plot collected data inorder to better determine compliance with a prescribed protocol andoverall progress of an individual patient. Likewise, the program willenable the healthcare provider to “program” the traction device 11, 92by setting forth, e.g. certain maximum and/or minimum limitations whichwill be implemented by the device 11, 92 via the microprocessor 71acting on the control mechanism 67 (which acts upon the electronic motor65). As discussed above, the “program” entered by the physician maycontrol the duration of use, force and extent of distraction, and/ordegree of rotation. Failure of a patient to meet a minimum requirementand/or breach of a maximum requirement may result in the device sendingan alarm or a (telephone or email) reminder, or the traction device 11,92 may merely disallow that rotation, amount of time and/or force andextent of distraction. This information can be used by the healthcareprofessional to monitor the patient's progress and “compliance” with thespecified therapy.

Another fundamental concept is that the patient will also be able to seeor obtain data regarding time of use, extent or forces applied and/ormovements. This information can be utilized by the patient to monitorthe patient's own progress and “compliance” with the specified therapy.

Methods

An exemplary method 80 of using a traction device 11, 92 is given inFIG. 8. According to step 81 of the method, various PPD 75 areoptionally registered to the PPD registration database 79. Next, perstep 82, a program is optionally set. As discussed above, setting aprogram may comprise selecting a pre-programmed therapy schedule ormanually entering program limitations for a single session or for atherapy schedule. Optionally, a user may operate the traction device 11,92 without implementation of a program.

The traction apparatus 11, 92 is disposed on the subject at step 83. Perstep 84, the traction of the device 11, 92 is adjusted. The traction maybe manually adjusted via e.g. the starwheel 57 illustrated in FIG. 2, orturnable knob 97 of FIG. 6 a, or may be adjusted electronically using anelectronic motor (e.g., FIG. 5) via a programmed adjustment programtransmitted from the microprocessor 71 to the control mechanism 67 whichcontrols the motor 65.

Per step 85, data regarding various aspects the use of the device 11, 92is recorded to the storage element 73 associated with the microprocessor71. The same collected data is then reported to a PPD 75 via step 86.The data may then be reported by, inter alia, wireless transmission,copying of the data to a removable storage medium which will be placedin communication with a PPD 75, via a wired transmission, etc.

It will be recognized that while certain aspects of the invention aredescribed in terms of a specific sequence of steps of a method, thesedescriptions are only illustrative of the broader methods of theinvention, and may be modified as required by the particularapplication. Certain steps may be rendered unnecessary or optional undercertain circumstances. Additionally, certain steps or functionality maybe added to the disclosed embodiments, or the order of performance oftwo or more steps permuted. All such variations are considered to beencompassed within the invention disclosed and claimed herein.

While the above detailed description has shown, described, and pointedout novel features of the invention as applied to various embodiments,it will be understood that various omissions, substitutions, and changesin the form and details of the device or process illustrated may be madeby those skilled in the art without departing from the invention. Theforegoing description is of the best mode presently contemplated ofcarrying out the invention. This description is in no way meant to belimiting, but rather should be taken as illustrative of the generalprinciples of the invention. The scope of the invention should bedetermined with reference to the claims.

1. Traction apparatus, comprising: a collar member, a head member, saidhead member being mated to said collar member such that said head membercan rotate relative to said collar member around a first axis, yet notmove substantially in a direction longitudinal along said axis; whereinsaid rotation allows the head of a wearer of said apparatus to rotate,yet substantially maintains a prescribed degree of traction on the spinethereof.
 2. The apparatus of claim 1, wherein said collar member isarticulated so that said head member and at least apportion of saidcollar member can rotate, relative to the remainder of said collarmember, around a second axis.
 3. The apparatus of claim 1, wherein saidarticulation comprises at least one hinge mechanism.
 4. The apparatus ofclaim 3, wherein said hinge mechanism comprises at least one lockedstate.
 5. The apparatus of claim 4, wherein said at least one lockedstate is associated with a particular degree of angular adjustment. 6.Traction apparatus, comprising: a collar member adapted to mate with thecollar region of a human being; a head member, said head member beingmated to said collar member in a substantially rotatable relationship;at least one sensor; and data storage apparatus, said data storageapparatus adapted to store data generated by said at least one sensorfor subsequent use.
 7. The apparatus of claim 6, wherein said at leastone sensor comprises a force or strain sensor.
 8. The apparatus of claim6, wherein said at least one sensor comprises an accelerometer.
 9. Theapparatus of claim 6, wherein said at least one sensor comprises arotation or position sensor adapted to sense the relative position ofsaid collar member and said head member.
 10. The apparatus of claim 6,further comprising a network interface adapted to transmit said datafrom said apparatus to a remote location over a network.
 11. Theapparatus of claim 10, wherein said network comprises a wireless localarea network (LAN).
 12. The apparatus of claim 6, further comprising aprocessor and computer program adapted to run thereon, said computerprogram being configured to monitor said at least one sensor andgenerate an alarm condition if one or more prescribed criteria areviolated while said user is wearing said apparatus.
 13. The apparatus ofclaim 6, further comprising: a force adjustment mechanism; and aprocessor and computer program adapted to run thereon, said computerprogram being configured to cause adjustment of said force adjustmentmechanism.
 14. The apparatus of claim 13, wherein said causingadjustment of said mechanism is performed in response to a commandissued from a remotely located computerized device.
 15. A method ofusing a cervical spine brace and traction apparatus comprising:disposing said apparatus on a subject; adjusting the distraction of saidapparatus; recording adjustment data relating to said apparatus; andtransmitting said adjustment data from said apparatus.
 16. The method ofclaim 15, wherein said act of adjusting the distraction of saidapparatus comprises manual adjustment of said apparatus.
 17. The methodof claim 16, wherein said manual adjustment is accomplished by rotationof an adjustment wheel.
 18. The method of claim 16, wherein said manualadjustment further comprises stopping an adjustment at a maximum and/orminimum permissible distraction.
 19. The method of claim 15, whereinsaid act of adjusting distraction of said apparatus comprises anelectronic adjustment of said apparatus.
 20. The method of claim 15,wherein said electronic adjustment is accomplished via an electroniccontrol mechanism adapted to control a motorized distraction adjustmentmechanism.
 21. The method of claim 15, further comprising running acomputer application, said computer application adapted to cause amicroprocessor on said apparatus to receive and implement programcriteria.
 22. The method of claim 21, wherein said program criteria isentered by a user, said program criteria comprising at least one of:maximum and/or minimum duration of use, maximum and/or minimum force ofdistraction, maximum and/or minimum extent of distraction, and maximumand/or minimum degree of rotation.
 23. The method of claim 22, furthercomprising triggering an alarm or signal if said entered criteria arenot met, said alarm or signal comprising at least one of: illuminationof a multi-colored LED light, an audible signal, or sending anelectronic message to a remote apparatus.
 24. The method of claim 22,wherein said program criteria is selected among stored program criteriaon said microprocessor; said program criteria comprising at least oneof: maximum and/or minimum duration of use, maximum and/or minimum forceof distraction, maximum and/or minimum extent of distraction, andmaximum and/or minimum degree of rotation.
 25. The method of claim 24,further comprising triggering an alarm or signal if said selectedcriteria are not met, said alarm or signal comprising at least one of:illumination of a multi-colored LED light, an audible signal, or sendingan electronic message.
 26. The method of claim 15, wherein said recordedadjustment data comprises at least one of duration of use, degree ofrotation, force of distraction, or extent of distraction.
 27. The methodof claim 15, wherein said adjustment data is recorded to an internalstorage device.
 28. The method of claim 15, wherein said adjustment datais transmitted to a device remote from said apparatus.
 29. The method ofclaim 15, wherein said remote device comprises a device registered witha database associated with said apparatus.
 30. The method of claim 15,wherein said transmission is wireless.
 31. The method of claim 29,wherein said registered remote device comprises a personal computer,said personal computer adapted to receive said adjustment data.
 32. Asystem for the use and analysis of a traction-based therapy, said systemcomprising: a cervical spine brace and traction apparatus adapted toperform traction-based therapy; a recording element, said recordingelement adapted to record adjustment data from said traction-basedtherapy; a transmitting element, said transmitting element being adaptedto transmit said adjustment data to a receiving device; a receivingdevice, said device being adapted to receive said adjustment data; andan analysis apparatus, said analysis apparatus adapted to analyze saidreceived adjustment data.
 33. The system of claim 32, wherein saidcervical spine brace and traction apparatus comprises a manuallyadjustable traction mechanism.
 34. The system of claim 32, wherein saidcervical spine brace and traction apparatus comprises an electronicallyadjustable traction mechanism adapted to perform at least one programmedtraction therapy program, said program stored on a storage device onsaid apparatus.
 35. The system of claim 32, wherein said cervical spinebrace and traction apparatus comprises an electronically adjustabletraction mechanism adapted to receive and implement a traction therapyprogram, said traction therapy program comprising user-entered programcriteria, said criteria entered into a microprocessor-based controlleron said apparatus.
 36. The system of claim 35, wherein said programcriteria comprise at least one of: maximum and/or minimum duration ofuse, maximum and/or minimum force of distraction, maximum and/or minimumextent of distraction, maximum and/or minimum degree of rotation. 37.The system of claim 32, wherein said adjustment data comprises at leastone of duration of use, degree of rotation, force of distraction, orextent of distraction.
 38. The system of claim 32, wherein saidrecording element comprises an external storage device in electroniccommunication with said apparatus.
 39. The system of claim 32, whereinsaid recording element comprises an internal storage device.
 40. Thesystem of claim 32, wherein said transmitting element comprises a wiredconnection to said receiving device.
 41. The system of claim 32, whereinsaid transmitting element comprises a wireless connection to saidreceiving device.
 42. The system of claim 41, wherein said receivingdevice is authenticated by registration with a registration database.43. The system of claim 42, wherein said receiving device comprises apersonal computer.
 44. A system for the utilization of traction-basedtherapy comprising: means for applying traction to the cervical spine ofa subject; means for recording adjustment data from said application oftraction; means for transmitting said adjustment data to a receivingdevice; means for receiving said adjustment data; and means foranalyzing said adjustment data.
 45. A computer readable apparatus, saidapparatus comprising a storage medium adapted to store a computerprogram thereon, said computer program comprising a plurality ofinstructions which when executed: receive adjustment data from atraction device; compare said adjustment data to pre-programmedstandards; and track a user's progress with regard to pre-programmedstandards.
 46. The apparatus of claim 45, wherein said program isfurther configured to: make recommendations regarding enhancement of auser's traction-based therapy progress; and transmit periodic updates toa set of pre-determined locations.
 47. The apparatus of claim 45,wherein said adjustment data comprises data regarding at least one of:(i) the degree of rotation of said traction device, (ii) the force ofdistraction of said traction device, (iii) the extent of distraction ofsaid traction device, or (iv) the duration of use of said tractiondevice.
 48. The apparatus of claim 45, wherein said pre-programmedstandards comprise standards entered by a healthcare provider prior touse, and wherein said traction device comprises a cervical spine braceand traction device adapted for use on a human being.
 49. A computerreadable apparatus, said apparatus comprising a storage medium adaptedto store a computer program thereon, said computer program adapted torun on a microprocessor in data communication with a traction apparatusand to: enable a user to enter identifying information; enable a user toenter program specifications to create a therapy program; and alert auser when one or more program specifications are breached.
 50. Theapparatus of claim 49, wherein said computer program is further adaptedto transmit periodic updates to one or more predetermined locations. 51.The apparatus of claim 49, further adapted to store a computer programthereon, wherein said microprocessor comprises a microprocessor locatedwithin a cervical spine brace and traction device.
 52. The computerreadable media of claim 49, further adapted to store a computer programthereon, wherein said program specifications comprise at least one of:maximum and/or minimum duration of use, maximum and/or minimum force ofdistraction, maximum and/or minimum extent of distraction, maximumand/or minimum degree of rotation.
 53. Traction apparatus comprising: acollar apparatus adapted to mate with the collar region of a subject; ahead support apparatus, said head support apparatus being mated to saidcollar apparatus by association through at least one substantiallyadjustable support member, said at least one support member comprisingat least one mechanism for moving said head support apparatus relativeto said collar apparatus so as to increase or decrease the tractionapplied to a user.
 54. The traction apparatus of claim 53, wherein saidat least one substantially adjustable support member comprises a singlesubstantially vertical beam.
 55. The traction apparatus of claim 53,further comprising: at least one sensor; and a data storage apparatus,said data storage apparatus adapted to store data generated by said atleast one sensor.
 56. The traction apparatus of claim 53, wherein saidhead support apparatus comprises first and second elements, said firstelement adapted to rotate relative to said second element around a firstaxis, yet not move substantially in a direction longitudinal along saidaxis.
 57. The traction apparatus of claim 56, wherein said first axis issubstantially parallel and coincident with a spinal column of said user.58. The traction apparatus of claim 56, wherein said head supportapparatus can rotate relative to said collar apparatus around a secondaxis.
 59. The traction apparatus of claim 56, wherein said rotationallows the head of said user to rotate, yet substantially maintains aprescribed degree of traction on the spine thereof.
 60. The apparatus ofclaim 55, wherein said at least one sensor comprises a force or strainsensor.
 61. The apparatus of claim 55, wherein said at least one sensorcomprises an accelerometer.
 62. The apparatus of claim 56, wherein saidat least one sensor comprises a rotation or position sensor adapted tosense the relative position of said first and second elements of saidhead support apparatus.
 63. The apparatus of claim 53, furthercomprising a network interface adapted to transmit said data from saidapparatus to a remote location over a network.
 64. The apparatus ofclaim 63, wherein said network comprises a wireless local area network(LAN).
 65. The apparatus of claim 55, further comprising a processor andcomputer program adapted to run thereon, said computer program beingconfigured to monitor said at least one sensor and generate an alarmcondition if one or more prescribed criteria are violated while saiduser is wearing said apparatus.
 66. The apparatus of claim 53, furthercomprising: a force adjustment mechanism; and a processor and computerprogram adapted to run thereon, said computer program being configuredto cause adjustment of said force adjustment mechanism.
 67. Theapparatus of claim 66, wherein said causing adjustment of said mechanismis performed in response to a command issued from a remotely locatedcomputerized device.